NDA 209472
`
`
`
`
`
`
` NDA APPROVAL
`
`
`
`Eagle Pharmaceuticals, Inc.
`
`Attention: Janis A. Picurro
`
`Senior Vice President, Regulatory Affairs
`
`50 Tice Boulevard
`
`Suite 315
`
`Woodcliff Lake, NJ 07677
`
`
`
`Dear Ms. Picurro:
`
`
`
`Please refer to your new drug application (NDA) submitted and received on
`
`December 30, 2016, and your amendments, submitted pursuant to section 505(b)(2) of
`
`the Federal Food, Drug, and Cosmetic Act for Pemfexy (pemetrexed injection)
`
`
`25 mg/mL.
`
`
`We acknowledge receipt of your amendment dated December 9, 2019, which
`
`constituted a complete response to our October 26, 2017, and October 9, 2019, action
`
`letters.
`
`
`This NDA provides for the use of Pemfexy:
`
`
`•
`
`
`
`in combination with cisplatin for the initial treatment of patients with locally
`advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC);
`
`as a single agent for the maintenance treatment of patients with locally advanced
`or metastatic non-squamous NSCLC whose disease has not progressed after
`four cycles of platinum-based first-line chemotherapy;
`
`
`as a single agent for the treatment of patients with recurrent, metastatic
`non-squamous NSCLC after prior chemotherapy; and
`
`•
`
`
`•
`
`
`•
`
`Reference ID: 4558342
`
`in combination with cisplatin for the initial treatment of patients with malignant
`
`pleural mesothelioma whose disease is unresectable or who are otherwise not
`candidates for curative surgery
`
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`
`on the date of this letter, for use as recommended in the enclosed agreed-upon
`
`labeling.
`
`
`

`

`NDA 209472
`
`Page 2
`
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
`Highlights of Prescribing Information. This waiver applies to all future supplements
`containing revised labeling unless we notify you otherwise.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information and Patient Package Insert) as well as annual reportable
`changes not included in the enclosed labeling. Information on submitting SPL files using
`eLIST may be found in the guidance for industry SPL Standard for Content of Labeling
`
`Technical Qs and As.2
`
`The SPL will be accessible via publicly available labeling repositories.
`
`
`CARTON AND CONTAINER LABELING
`
`
`Submit final printed carton and container labeling that are identical to carton and
`container labeling submitted on January 15, 2020, as soon as they are available, but no
`more than 30 days after they are printed. Please submit these labeling electronically
`according to the guidance for industry Providing Regulatory Submissions in Electronic
`Format — Certain Human Pharmaceutical Product Applications and Related
`Submissions Using the eCTD Specifications. For administrative purposes, designate
`this submission “Final Printed Carton and Container Labeling for approved
`NDA 209472.” Approval of this submission by FDA is not required before the labeling is
`used.
`
`
`ADVISORY COMMITTEE
`
`Your application for Pemfexy was not referred to an FDA advisory committee because
`this drug is not the first in its class and the safety profile is similar to that of other drugs
`approved for this indication.
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4558342
`
`

`

`NDA 209472
`
`Page 3
`
`
`indications, new dosage forms, new dosing regimens, or new routes of administration
`
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`We are waiving the pediatric studies requirement for this application because necessary
`studies are impossible or highly impracticable due to the rarity of pediatric patients with
`non-squamous non-small cell lung cancer (NSCLC) and malignant pleural
`mesothelioma.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. To do so, submit, in triplicate, a cover letter requesting advisory
`comments, the proposed materials in draft or mock-up form with annotated references,
`and the Prescribing Information, Medication Guide, and Patient Package Insert (as
`applicable) to:
`
`
`OPDP Regulatory Project Manager
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Office of Prescription Drug Promotion
`
`5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD
`format. For more information about submitting promotional materials in eCTD format,
`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
`Non-Electronic Format—Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
`and the Prescribing Information, at the time of initial dissemination or publication,
`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
`
`Information and Instructions for completing the form can be found at FDA.gov.5 For
`more information about submission of promotional materials to the Office of Prescription
`
` Drug Promotion (OPDP), see FDA.gov.6
`
`
`
`3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
`version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
` 6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4558342
`
`

`

`NDA 209472
`
`Page 4
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
` If you have any questions, call Meredith Libeg, Senior Regulatory Health Project
`
`Manager, at (301) 796-1721.
`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`
`
`Harpreet Singh, M.D.
`
`Director (Acting)
`
` Division of Oncology 2 (DO2)
`
`
`Office of Oncologic Diseases (OOD)
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`ENCLOSURE(S):
`
` Content of Labeling
`o Prescribing Information
`
`o Patient Package Insert
`
`
`
` Carton and Container Labeling
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4558342
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`B HARPREET SINGH
`02/08/2020 09:16:29 AM
`
`Reference ID: 4558342
`
`